Penile Lengthening Pre-Penile Prosthesis Implantation

Conditions:Erectile Dysfunction
Therapuetic Areas:Nephrology / Urology
Age Range:18 - Any
Start Date:March 23, 2018
End Date:March 23, 2021

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This study is intended to utilize a novel, class I (ie. lowest risk, clinical studies not
required) medical device to determine whether penile length can be increased in men prior to
undergoing a penile prosthesis implantation procedure.

Men with erectile dysfunction, unresponsive to conservative therapies, are recommended to
undergo placement of an inflatable penile prosthesis (IPP); however, it is a common complaint
post-operatively that their penis length is shorter than what it was previously.

Several attempts have been made by investigators to optimize penile length prior to placement
of the penile prosthesis. Compared to other options, penile traction therapy (PTT) offers
several potential advantages in that it is minimally-invasive, does not increase the
morbidity of surgery, and has not been shown to result in any long-term side effects.

A new penile traction device (RestoreX® ) was created and funded through Mayo Ventures. Given
the clinical issue of dissatisfaction with penile length post IPP, the potential role for
PTT, and limited amount of data available, we sought to perform a clinical trial evaluating
the effect of PTT on increasing the total length of prosthesis which can be inserted. We
additionally sought to determine if PTT resulted in improved post-operative satisfaction on
total penile length achieved.

To accomplish the study, a population of men from Mayo Clinic planning to undergo placement
of an IPP will be enrolled and given the option to either join the control (no treatment)
group or PTT group for 3 months prior to their procedure. Outcomes will be assessed prior to
surgery and 3, 6, and 12 months post-procedure. Results are to be used with the intent to
publish in a scientific journal.

Inclusion Criteria

- Men undergoing placement of a penile prosthesis

- Must be the first time a penile prosthesis is implanted

- Undergoing implantation of a 3-piece inflatable penile prosthesis

Exclusion Criteria

- Prior ischemic priapism

- Any prior penile prosthesis surgeries

- Any prior penile surgeries other than circumcision

- Undergoing malleable penile prosthesis or Ambicor device
We found this trial at
200 First Street SW
Rochester, Minnesota 55905
Phone: 507-538-6151
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
Rochester, MN
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Phone: 314-574-7366
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
Saint Louis, MO
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